Assessment of Cognitive Functioning Before and After Treatment With Duloxetine (DULOX)

The University of Texas System (UT)

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Drug: Duloxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00933439

Duloxetine

Details and patient eligibility

About

The purpose of this study is to study the effect of duloxetine treatment on (1) cognitive functions, the brain mechanisms involved with thinking, reasoning, learning, and remembering; (2) psychosocial functions, how someone interacts with his/her social environment; and (3) the relationship between these two functions, in people who have major depressive disorder, a severe form of depression.

Full description

People who have difficulties with concentration and/or cognition as part of their depression will be treated with duloxetine for 12 weeks and their cognitive performance will be assessed before and after treatment using cognitive tests. Eligible participants will have eight clinic visits.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ability and willingness to provide written informed consent
Primary diagnosis of Major Depressive Disorder (MDD)
Age 18-45
Screening and baseline Hamilton Rating Scale for Depression (HRSD) 17-item score greater than or equal to 16 or Clinical Global Impression (CGI) score of at least 4
Subjective report of difficulties with cognition and/or concentration and score of 2 or greater on the Inventory for Depressive Symptomatology (IDS-C(30)) item addressing this symptom (#16: Concentration and Decision Making)

Exclusion criteria

Presence of significant comorbid condition based on laboratory tests, physician information, or evidence at examination
Patient report or evidence (based on physical examination or laboratory tests) of existing liver disease
Presence of other psychological disorders, including depression due to other comorbid conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia, or schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse within the last 6 months, or patients with comorbid psychiatric conditions that are relative or absolute contraindications to the use of duloxetine
Concomitant pharmacological or psychotherapeutic treatment including but not limited to antidepressants, anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy, cognitive behavioral therapy; current use of other medications that would be contraindicated with duloxetine, as determined by the study doctor
Hospitalization for mental illness within the past year
Not fluent in spoken and written English
For women, currently pregnant, planning to become pregnant in the next year, or breastfeeding